FDA Stregnthens Warnings on Gadolinium MRI DyesSep 9, 2010 | Parker Waichman LLP
Gadolinium-based contrast dyes will now bear new warnings on their labels regarding their association with nephrogenic systemic fibrosis (NSF), according to the Food & Drug Administration (FDA). Gadolinium-based contrast dyes are intravenous drugs approved by the FDA for use with magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) to help detect abnormalities of body organs, blood vessels, and other tissues.
Three of the dyes, Bayer Healthcare’s Magnevist, GE Healthcare’s Omniscan, and Covidien’s Optimark, will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease. All gadolinium contrast dye labels will emphasize the need to screen patients to detect these types of kidney dysfunction before administration, the FDA said.
In a statement, the FDA said these label changes are intended to help ensure these drugs are used appropriately, and that patients at risk for NSF who receive these agents are actively monitored for the development of the disease.
In its announcement, the agency said its safety review of the most widely used gadolinium agents determined that Magnevist, Omniscan, and Optimark are associated with a greater risk than other gadolinium contrast dyes for NSF in certain patients with kidney disease.
To further enhance the safe use of the imaging agents, the FDA further recommends that health care professionals:
• Estimate kidney function through laboratory testing for patients at risk for chronically reduced kidney function.
• Avoid use of gadolinium contrast agents in patients suspected or known to have impaired drug elimination unless the imaging is essential and not available without contrast.
• Monitor for signs and symptoms of NSF if a gadolinium is administered to a patient with acute kidney injury or chronic, severe kidney disease.
• Administer a gadolinium contrast agent only once during an imaging session.
NSF leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death.
While not much is known about the disease, a growing mountain of evidence indicates that NSF is most likely to occur in people with severe kidney disease who have been exposed to a gadolinium contrast dyes. Since 2007, all gadolinium agents sold in the U.S. have carried the same black box warning – the FDA’s strongest safety notice – regarding the risk of NSF.
GE Healthcare and the other makers of gadolinium agents are named in approximately 500 lawsuits filed by NSF patients, most of which have been consolidated in the U.S. District Court for the Northern District of Ohio as part of a multidistrict litigation (MDL) before Judge Dan Polster.